NCT01962987

A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis

A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Diclofenac Sodium Gel 3% (Actavis) to Solaraze ® (Diclofenac Sodium) Gel 3% (Fougera Pharms) in the Treatment of Actinic Keratosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 476 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3% (Actavis) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) in the treatment of the actinic keratosis

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Diclofenac sodium	Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
OTHER	Placebo	Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2013-10-16
• Last updated: 2020-07-20
• Results posted: 2020-07-20

Locations

31 sites across 1 country: United States